Medicinal Products

ACICLOVIR SANDOZ 250 mg

Generic drug of Zovirax
Therapeutic class: Infectiology - Parasitology
active ingredients: Aciclovir
laboratory: Sandoz

Powder for solution for injection IV
Box of 1 250 mg bottle
All forms

Indication

IN THE SUBJECT IMMUNODEPRIME:
- infections with Varicella Zona virus (VZV),
- Herpes Simplex virus infection (HSV).
IMMUNOCOMPETENT SUBJECT:
- VZV infections:
. shingles by the extension or progression of the lesions,
. chickenpox in the pregnant woman whose eruption occurs within 8 to 10 days before delivery,
. chickenpox of the newborn,
. the newborn before any eruption, when the mother has started chickenpox in the 5 days before and 2 days after delivery,
. severe forms of chicken pox in children under 1 year old,
. complicated chickenpox, especially varicella pneumonia,
- HSV infections:
. severe herpes genital primo-infection,
. treatment of acute herpetic gingivostomatitis, when functional discomfort makes the oral route impossible,
. treatment of Kaposi Juliusberg syndrome,
. treatment of herpes meningoencephalitis.

Dosage ACICLOVIR SANDOZ 250 mg Powder for solution for injection IV Box of 1 vial of 250 mg

Dosage:
- In adults:
. Infections with varicella zoster virus (VZV) : 10 mg / kg every 8 hours, 15 mg / kg every 8 hours in pregnant women.
. Herpes simplex virus (HSV) infections (except meningoencephalitis) : 5 mg / kg every 8 hours.
. Herpetic meningoencephalitis : 10 mg / kg every 8 hours.
- In children older than 3 months, in some cases it is necessary to calculate the dose according to body surface area:
. HSV (except meningoencephalitis) or VZV infection : 250 mg / m² every 8 hours (approximately 10 mg / kg every 8 hours). . HSV meningoencephalitis or severe VZV infection in immunocompromised children : 500 mg / m² every 8 hours (approximately 20 mg / kg every 8 hours). - In the newborn, 20 mg / kg every 8 hours.
- In patients with renal insufficiency, the interval between two administrations and the posology will be adapted according to the clearance of creatinine:
Creatinine clearance: Unit dose / Frequency.
. 25-50 ml / min :
5 mg / kg for HSV infections / 2 times per 24 hours.
10 mg / kg for VZV infections and herpes meningoencephalitis / 2 times per 24 hours.
20 mg / kg for infant meningoencephalitis / 2 times per 24 h.
. 10-25 ml / min :
5 mg / kg for HSV infections / 1 time per 24 hours.
10 mg / kg for VZV infections and herpes meningoencephalitis / once every 24 hours.
20 mg / kg for infant meningoencephalitis / once every 24 hours.
. 0-10 ml / min :
2.5 mg / kg for HSV infections / 1 time per 24 hours.
5 mg / kg for VZV infections and herpes meningoencephalitis / once every 24 hours.
10 mg / kg for meningoencephalitis in infants / once every 24 hours.
On the day of hemodialysis, the dose should be administered after dialysis.
Administration mode :
- Intravenous strict route.
- Each dose will be injected intravenously (by pump or infusion) in one hour minimum.
- The duration of the treatment is in general:
. from 8 to 10 days for Varicella Zona virus infections,
. 10 days for the treatment of herpes meningoencephalitis, it must be adapted according to the patient's condition and response to treatment,
. 5 to 10 days for other Herpes simplex virus infections .

Against indications

- This medication should not be used if there is a history of hypersensitivity to aciclovir, or any of the other ingredients of the powder.
- Breast-feeding: In the case of a serious condition requiring general maternal treatment, breast-feeding should be avoided.

Adverse effects Aciclovir Sandoz

- Rare mild rashes regressing when treatment is stopped. - Kidney problems with increased blood urea and creatinine occurring most often after intravenous administration too fast. They can be avoided by respecting the dosages, the precautions of use and the speed of administration. - Some observations of regressive neurological disorders (in particular ebbing sensations, confusion, hallucinations, somnolence) have been reported: they are usually renal insufficiency patients who have received doses above the recommended dosage or at risk patients (especially the elderly - see section warnings and precautions for use).
- Digestive disorders, increased levels of bilirubin or transaminases, headache, asthenia. These disorders are rare and benign; they have always regressed, sometimes even despite continuing treatment. - Rare skin lesions instead of injection, which can exceptionally go to necrosis, in case of extravasation or insufficient dilution of the solution (see paragraph instructions for use, handling and disposal). These side effects are related to the alkaline pH of this medicine.

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